Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deuruxolitinib, Placebo.
- Who it may be relevant to
- Registry conditions: Alopecia Areata. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adult Patients With Severe Alopecia Areata With an Open-Label Extension Period
Overview
This study evaluates the efficacy and safety of deuruxolitinib in Japanese Adults between 18 and 65 years of age who have 50% or greater scalp hair loss.
Detailed description
The efficacy and safety of deuruxolitinib in adult subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects between 18 and 65 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, all participants from the Treatment Period will receive deuruxolitinib for 52 weeks.
Interventions
- Drug Deuruxolitinib
Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg - Drug Placebo
Deuruxolitinib matching placebo will be dosed orally as tablets for up to 24 weeks and then deuruxolitinib will be dosed for up to 52 weeks
Primary outcome measures
- Percentage of subjects achieving an absolute SALT score of 20 or less [Time frame: Week 24]
Secondary outcome measures (12)
- Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale [Time frame: Week 24]
- Percentage of subjects achieving an absolute SALT score of 20 or less [Time frame: Weeks 12, 16, and 20]
- Relative change in SALT scores from baseline [Time frame: Weeks 4, 8, 12, 16, 20, and 24]
- Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I [Time frame: Weeks 12, 16, 20, and 24]
- Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I [Time frame: Weeks 12, 16, 20, and 24]
- Change from baseline in CGI-S [Time frame: Weeks 12, 16, 20, and 24]
- Change from baseline in PGI-S [Time frame: Weeks 12, 16, 20, and 24]
- Percentage of subjects achieving at least a 75% relative reduction in SALT score from baseline [Time frame: Weeks 12 and 24]
- Percentage of subjects achieving at least a 90% relative reduction in SALT score from baseline [Time frame: Weeks 12 and 24]
- Change from baseline in the Eyebrow Clinician-Reported Outcome (ClinRO) score [Time frame: Weeks 12 and 24]
- Change from baseline in the Eyelash Clinician-Reported Outcome (ClinRO) score [Time frame: Weeks 12 and 24]
- Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale [Time frame: Weeks 12, 16, and 20]
Eligibility criteria
Inclusion criteria
- Written informed consent has been obtained.
- Japanese subjects with severe alopecia areata who are between 18 and 65 years of age, inclusive, at the time of informed consent.
- Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months.
- SALT score of 50 or more at both Screening and Baseline.
Exclusion criteria
- Treatment with systemic immunosuppressive medications or agents, including Janus kinase inhibitors, within 4 months prior to randomization.
- Treatment with biologics within 6 months prior to Screening.
- Positive test results for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus at Screening.
- History of active tuberculosis, a positive interferon gamma release assay at Screening, or evidence of tuberculosis-related lesions on chest radiography.
- Clinically significant hematologic abnormalities, hepatic impairment, or renal impairment at Screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Japan · 18 centers
- Study Site 102 — Asahikawa
- Study Site 117 — Bunkyō City
- Study Site 119 — Ebina
- Study Site 101 — Hamamatsu
- Study Site 116 — Ishikawa
- Study Site 112 — Kitakyushu
- Study Site 118 — Kōtoku
- Study Site 110 — Kurashiki
- … and 10 more centers
Identifiers
NCT: NCT07617597 · CTP-543-25-01JP · jRCT2031260062